FDA.report

Winner EVO Combo

Primary DI
00853904006155
Brand
Winner EVO Combo
Company
Compass Richmar, LLC
Model
410-012
Device description
Winner EVO-CM4
Published
2016-11-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LIHInterferential Current Therapy

Product Code Classifications

CodeDeviceSpecialtyClass
LIHInterferential Current TherapyNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00853904006155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00853904006155008539040061558539040061550853904006155

GMDN Terms

TermDefinition
Physical therapy ultrasound/neuromuscular stimulation systemAn assembly of devices that includes a neuromuscular electrical stimulator as an integral part of a therapeutic ultrasound system intended for the simultaneous delivery of ultrasound and electrical energies for physical therapy, typically to help prevent scar tissue formation in healing tissues and to help reduce muscle spasms and pain; it may in addition be capable of delivering either energy alone. The system is designed to produce a rhythmic contraction/release of injured muscles to promote the removal of metabolic by-products while applying ultrasound treatments.

Sterilization Methods

Method

Contacts

PhoneEmail
1-888-549-4945customerservice@richmarweb.com
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags

DUNS number
080930531
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10850689007404STICK-E-PADS203-6772016-11-18
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10850689007442ValueStim202-6762016-11-18
10850689007466Adhesive Electrodes202-4542016-11-18
10850689007473Adhesive Electrodes202-4552016-11-18

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00860012519507CPS-2000SURGITECH, INC.LIH2025-03-31
00860012846917HakomedHAKOMED ASIA COMPANY LIMITEDLIH2024-10-08
24712832961182GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-04
24712832961250GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-04
24712832961274GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-04
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24712832961403GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-04
24712832961410GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-04
24712832961427GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-04
24712832961045GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-01
04712832961058GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-01
04712832961065GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-01
04712832961072GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-01
24712832961083GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-01
04712832960211GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-08-18
24712832960475GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-08-18
00860009424708CS6101 Interferential StimulatorControl Solutions LLCLIH2023-03-20
00860009424715CS6101 Interferential KitControl Solutions LLCLIH2023-03-20
00860009424722CS6101 Interferential KitControl Solutions LLCLIH2023-03-20
00860009424739High Voltage Galvanic StimulatorControl Solutions LLCLIH2023-03-20
00860009424746High Voltage Galvanic Stimulator KitControl Solutions LLCLIH2023-03-20
00860009424753High Voltage Galvanic Stimulator KitControl Solutions LLCLIH2023-03-20
00860009424760CS6101-2 Interferential StimulatorControl Solutions LLCLIH2023-03-20
00860009424777Leadwire Set for CS6101 StimulatorControl Solutions LLCLIH2023-03-20
00860009424784Leadwire Set for CS6102 StimulatorControl Solutions LLCLIH2023-03-20
00860009424791CS6101-1 Interferential StimulatorControl Solutions LLCLIH2023-03-20
00860009424807CS3101-TL2 Interferential StimulatorControl Solutions LLCLIH2023-03-20
00860009424814AC Power Adapter for CS6101 StimulatorControl Solutions LLCLIH2023-03-20
00860009424821AC Power Adapter for CS6102 StimulatorControl Solutions LLCLIH2023-03-20
00860009424838CS6101-3 Interferential StimulatorControl Solutions LLCLIH2023-03-20